Technical Writing Support for GxP Compliance

Freyr's technical writing services deliver clear, concise SOPs and document templates to ensure regulatory quality and compliance. Our expert writers craft documents that are easy to understand and implement, supporting GxP operations.

Technical Writing Support for GxP Compliance - Overview

Guidelines, Standard Operating Procedures (SOPs), and document templates are the backbone of pharmaceutical and Regulatory industries. SOPs and document templates are not just a preference, it is a legal requirement.

Freyr has an in-house technical writing capability that enables consistent, organized, and straightforward document language, used to execute the successful completion of GxP and critical business-controlled tasks. We provide end-to-end Regulatory support with guidelines insights, drafting of the SOPs, and document templates which will fulfill the highest levels of quality, safety, and Regulatory compliance.

The content is developed as simply and as effectively as possible, ensuring easy language for readers in a way that they can understand and apply, even without prior knowledge of the subject matter.

Our Technical Writing services include:

  • Draft the document following the sponsor-specific template (or Freyr template) and style guide
  • Quality review and document proofreading
  • Manage the workflow system for SOPs, guidance documents, work instructions, etc.
  • Manage project timelines in coordination with the sponsor's requirements.
  • Ensure periodic review changes and updates

Technical Writing Support for GxP Compliance

  • A Team of experienced technical writers who are skilled in translating complex technical information into clear and concise documents
  • In-depth knowledge of industrial standards and best practices for technical writing
  • Qualified Subject matter experts provide insights and technical knowledge that enhance the quality and accuracy of the technical writing projects
  • Support review and template alignment activities
  • Support document authoring for updates and workflows
  • Alignment with quality management system (QMS) workflow and administration
  • Perform proofreading, periodic reviews, and co-authoring with authors/ SMEs as per requirements
  • Execution of document development for major re-write or new document preparation
  • Manage project timelines with Authors/SMEs
Technical Writing Support for GxP Compliance
  • Team of Technical writers (TW) with diverse skills and expertise for comprehensive support
  • Technical writers skilled in working with styles, formatting, and publishing within MS Suite
  • Team of Qualified members to manage multiple projects and prioritize in stipulated timelines
  • Freyr TW team focuses on driving consistency of documentation, efficiency of workflows, quality of content, and effectiveness of process
  • Efficient in the communication of complex technical concepts and providing cost-effective solutions for technical writing needs
Technical Writing Support for GxP Compliance

Celebrating Customers Success

 

Medicinal Products

Medical Writing

India

A big thanks to Freyr team for the support they have provided to us on priority. We really appreciate the extra effort that the Freyr team has put into providing the reports on time. We are looking forward for a continuous business association with Freyr.

Head of Quality Assurance

 

Medicinal Products

Medical Writing

India

A big thanks to the Freyr team for the support they have provided to us on priority. We really appreciate the extra effort that the Freyr team has put into providing the reports on time. We are looking forward to a continuous business association with Freyr.​

Head of Quality Assurance​

India-based, Leading Pharma Contract Manufacturing Organization​

 

Medicinal Products

Medical Writing

UK

We are extremely happy to inform you that the BLA was successfully submitted to the FDA. We convey our sincere gratitude to the Freyr team, who worked diligently, tirelessly, and very closely with our Bridgewater and Beijing teams over the past several months to accomplish this monumental feat on time. Freyr’s team went beyond the call of duty to make this BLA submission come true. We truly appreciate Freyr’s flexibility and eagerness to work with us to accomplish aggressive goals. Look forward to your perennial support and our continued relationship and beyond. ​

Global CMC Technical Lead​

China-based, Leading Innovator Pharmaceutical Company​

 

Medicinal Products

Medical Writing

USA

Thank you, Freyr team. I appreciate your professionalism, dedication, and hard work. You’ve gone above and beyond to ensure all deliverables were met ahead of schedule throughout the project and have done a great job managing a challenging group of products. I appreciate your attention to detail and follow-up on the large workload you’ve managed. It’s been a pleasure working with you, and I wish you and your family all the best in the future!​

Director, Global Labeling Management – Labeling Cluster Head Global Product ​ Development, Global Regulatory Affairs

US-based, Multinational Pharmaceutical and Biotechnology Company​

 

Medicinal Products

Medical Writing

Vietnam​

Thank you so much for being a great partner in our Regulatory compliance journey.

As Asian countries move towards having safety assessments as a key requirement, your support has helped us significantly in fulfilling those requirements well ahead of our competitors in Vietnam. ​

In fact, I shared your contact with our regulatory officers so that they can share it across the industry if the safety assessments become necessary.

Lead, R&D/Personal Care

India-based, Multinational Consumer Goods Company​

 

Medicinal Products

Medical Writing

USA

Kudos to you all for the brilliant teamwork !! Alone, we can do so little; together, we can do so much.

Look forward to the next milestone and collaboration on new projects in the future.

SVP - R&D ( Finished Dosage Form)​

US-based, CRO Company that Focuses on Material Science and Engineering for Drug Development​